SALT LAKE CITY–(BUSINESS WIRE)– XableCath, a clinical stage medical device company, announced its XableCath blunt tip support catheter has received clearance from the FDA. The blunt tip catheter facilitates true lumen passage of lesions, both above and below the knee, in the peripheral vasculature. Procedures using the XableCath blunt tip catheters can be performed quickly and safely, allowing physicians to more effectively treat peripheral arterial disease (PAD).

“In two clinical investigator-led studies, XableCath was demonstrated to be a safe, effective, and easy-to-use device, enabling therapeutic options for patients with PAD,” said Johannes Dahm, M.D., Director of Interventional Cardiology & Angiology, Heart & Vascular Center Neu-Bethlehem, Göttingen, Germany. “The XableCath blunt tip catheter is unique in its ability to cross chronic total occlusions quickly while remaining over-the-wire and in the true lumen. XableCath catheters will be powerful tools in the interventional suite.”

The company expects to perform its first U.S. cases in the first half of 2018.

“I am excited to use the XableCath devices in my practice, because I believe it will enhance our ability to treat difficult occlusions and ultimately help our patients,” said James Benenati, M.D., Medical Director, Noninvasive Vascular Laboratory and Fellowship Program Director at the Miami Cardiac & Vascular Institute at Baptist Hospital in Miami, Florida. “XableCath addresses an unmet clinical need, and we believe it will allow us to succeed in treating patients with complex occlusive disease.”

XableCath President and CEO, Lisa Dunlea commented, “Different from most interventional devices used to facilitate lesion passage, XableCath was designed to be one of the best support catheters and to facilitate over-the-wire lumen passage, minimizing the need for multiple products and exchanges and reducing procedure time. We believe that our catheters will quickly integrate into standard clinical practice to the benefit of both patients and physicians. With the success of our products in PAD, we are excited to apply our innovative technologies to future coronary and atherectomy products.”

About XableCath

XableCath was founded in 2014 to commercialize catheters for the treatment of vascular disease. XableCath technology is revolutionary and allows effective treatment, improving the lives of patients and transforming the ease of vascular interventions for physicians. For more information visit www.xablecath.com.

For most people, their first indication of cardiovascular disease occurs when they have a heart attack or a stroke. For too many people it is the last thing they ever experience.

However, a group of researchers at the University of Michigan have taken a scanning fiber endoscope, or SFE, which was originally built to provide early detection of cancer and has turned it to a new purpose, the early detection of arteriosclerosis, according to Geek Wire. The SFE, a fiber optic device with a laser scanning camera, was inserted into the blood vessels of rabbits and into harvested arteries to look for signs of disease that could lead to a heart attack or stroke.

As a result the researchers were able to obtain high-resolution images from the insides of arteries that detected the presence of lesions that could later lead to a cardiovascular event. The resulting images are the most detailed yet, picking up potential problems that hitherto had remained hidden.

The technique could be used on people at high risk of developing a heart attack or stroke due to lifestyle choices or family history. It could also be used to find out the cause of a stroke or other event that is not obvious to conventional scans.

As with any other illness, the way to deal with cardiovascular disease is not to have it to start with. If the SFE scan can be developed for a clinical setting, doctors can detect causes of oncoming strokes and heart attacks before they happen and take appropriate action.

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Every minute a person in United States dies from a cardiovascular disease related condition. Heart disease is the number one cause of death in the U.S., according to statistics published by the Center for Disease Contol. It costs hundreds of billions in lost productivity and health care.

Those who have cardiovascular disease, regardless of gender or race, are usually 55 years or older. For heart disease prevention, considering the risk factors in life style changes, is worthwhile. For those who have this disease, treatment is the best option. Of the many treatments and technologies for heart disease and related conditions, there are some recent findings and breakthroughs of interest. Some of these discoveries have FDA approval and some hold promise.

Transcatheter aortic valve replacement device, called TAVR, is used in surgery to treat patients with heart valve diseases. This is useful for those who cannot have open heart surgery. Study is still under way.

Drugs to block the protein RBPJ. This protein is responsible for controlling genes required for the growth of blood vessels in the damaged heart, following a heart attack.

Inserting stent through wrist of patient with heart disease, lowers bleeding and risk of death.

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Researchers recently looked at data from more than 91,000 patients who were admitted to hospitals in California with the diagnosis of a heart attack between the years of 2001 and 2011. The study did not find a meaningful difference in the rates of survival one year out between races when the hospital was not experiencing overcrowding or was only on diversion for six hours or less on the date the patient presented to the ER with AMI symptoms. However, when hospitals diverted ambulances for longer periods of time, African American patients were more likely to suffer death during the first year after their heart attack, the retrospective study found. The study was reported in the Journal of Health Affairs.

“Black patients still fared worse compared to white patients even though both experienced the same level of diversion, had the same access to technology, received the same measurable treatment, and were treated in similar hospitals,” said lead study author Dr. Renee Hsia, an emergency physician at Zuckerberg San Francisco General Hospital and Trauma Center.

The Problem with Diversion

Ambulances are diverted when an ER becomes too crowded, or a hospital experiences an influx of patient admissions that threaten their capacity. The goal is always to send patients to hospitals where they can receive prompt attention. The problem is that the nearest hospital is usually several minutes to a few hours away, by ambulance. This leaves many in a precarious situation.

The Disparity

The study found a larger percentage of African American patients were regularly diverted, presumably due to chronic overcrowding in urban hospitals as opposed to rural or suburban hospitals.

48 percent of white patients were diverted

52 percent of black patients were diverted

Furthermore, when black patients suffered a heart attack on a day that the hospital nearest them was on diversion for 6 -12 hours, their odds of dying within the first year increased by 4.1 percentage points over white patients. When the diversion for the hospital lasted 12 hours or more African American patients showed close to a 19 percent increase in risk relative to Caucasian patients, the study authors pointed out.

Missing Data: Arrival Methods

One item was glaringly missing from the study: patient arrival methods. Is it possible that African American patients are traveling to urban hospitals from nearby neighborhoods, arrived by car instead of an ambulance? Perhaps this could account for some of the unexplained disparity. When an ER is on diversion, ambulance companies are made aware immediately. However, patients arriving by car may not be aware of the overcrowding issue, causing an increase in the time from door to the cath lab in the case of AMI.

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One of the pernicious effects of cardiovascular disease is that it creates scar tissue on the heart, which in turn disrupts normal pumping of a person’s blood, a phenomenon that can lead to heart failure due to cardiovascular disease. However, according to News Medical Net, a researcher at the University of Texas Southwest Medical Center may have found a way to address this problem using a cancer drug.

Dr. Lawrence Lum, Associate Professor of Cell Biology, was working on a drug that would target a molecule that promotes tissue regeneration, which can contribute to the growth of cancer tumors. The so-called Porcupine enzyme is essential for the operation of this molecule. Lurn and his team noticed something strange about a porcupine enzyme inhibitor they had developed in that it caused the number of dividing heart muscle cells to increase. The inhibitor could be used for regeneration of heart muscles after a heart attack, avoiding much of the scarring that takes place.

To test the theory, Lurn induced heart attacks in mice and then treated them with the inhibitor. Not only did normal heart action return far more than would ordinarily be the case, but scarring was decreased as well. The inhibitor would only have to be used for a short time, thus lessening any side effects.

The next step for the development of the heart regeneration drug will be to go into clinical trials which Lurn hopes will occur within the next year or so. If and when the inhibitor becomes available in a clinical setting, deaths from heart failure could be vastly diminished even for those patients who have suffered heart attacks.

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